NCT05818462

Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors

Effect of Pelvic Radiation Therapy on the Urinary and Musculoskeletal Systems of Survivors of Childhood Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 2 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization.

Detailed description

The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization. The overarching hypothesis is that patients who received EBRT to the pelvis will have an increased rate of LUT dysfunction and osteoporosis even when controlled for chemotherapeutic exposures, using patients with similar chemotherapy regimens as controls. Between these two groups, the team expect to observe significant differences in both patient-reported outcomes and direct measures of LUT function.

Conditions

• Cancer
• Childhood Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Uroflow testing	Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.
DIAGNOSTIC_TEST	Bladder Scan	Bladder scan measures ultrasonic reflections within the patient's body to differentiate the urinary bladder from the surrounding tissue. In this case, it is used to detect the volume of urine in the bladder.
OTHER	Dysfunctional Voiding Scoring System Survey	The Dysfunctional Voiding Symptom Score to provide accurate and objective numerical, grading of voiding behaviors of children.
DIAGNOSTIC_TEST	DEXA Scan of pelvis and sacral spine	DEXA (dual x-ray absorptiometry) scans measure bone density (thickness and strength of bones) by passing a high and low energy x-ray beam (a form of ionizing radiation) through the body, usually in the hip and the spine.
DIAGNOSTIC_TEST	Urine tests for specific biomarkers	Urine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening).

Timeline

• Start date: 2023-07-11
• Primary completion: 2025-05-02
• Completion: 2025-05-02
• First posted: 2023-04-18
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States